Position Overview:
As the Quality Manager, you will be responsible for ensuring the highest quality standards in the development and production of biomedical products. You will lead and manage quality assurance activities across the production process, ensuring compliance with regulatory requirements, industry standards, and company policies. You will play a pivotal role in driving continuous improvement initiatives and fostering a culture of quality within the organization.
Key Responsibilities:
- Oversee and manage the company's Quality Management System (QMS), ensuring compliance with ISO 13485, FDA regulations, and other applicable standards.
- Develop, implement, and maintain quality assurance policies and procedures.
- Lead quality audits, internal and external inspections, and regulatory compliance assessments.
- Monitor and report on quality performance metrics, identifying trends and areas for improvement.
- Manage the resolution of non-conformances, corrective actions, and root cause analysis.
- Collaborate with cross-functional teams (e.g., R&D, Manufacturing, Regulatory Affairs) to ensure product quality throughout the product lifecycle.
- Ensure proper documentation and traceability for all quality-related activities.
- Train and mentor staff on quality processes and regulatory requirements.
- Maintain relationships with regulatory bodies, customers, and suppliers to ensure ongoing compliance and quality standards.
